Presentation Abstract

Session: 97-New Antiretrovirals
Monday, Sep 13, 2010, 11:15 AM - 1:15 PM
Presentation Title: H-938b - The Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF; Quad) Maintains a High Rate of Virologic Suppression, and Cobicistat (COBI) is an Effective Pharmacoenhancer Through 48 Weeks
Location: Exhibit Hall B1
Poster Board Number: 403
Presentation Number: H-938b
Pres. Time: Monday, Sep 13, 2010, 11:15 AM - 1:15 PM
Category: H
Keywords: integrase inhibitor ; antiretroviral therapy ; pharmacoenhancer 
Author(s): R. ELION1, J. GATHE 2, B. RASHBAUM 3, P. SHALIT 4, T. HAWKINS 5, H. C. LIU 6, L. ZHONG 6, D. R. WARREN 6, B. P. KEARNEY 6, S. L. CHUCK 6;
1Whitman Walker Clinic, Washington, DC, 2Therapeutic Concepts, P.A., Houston, TX, 3Capital Med. Associates, PC, Washington, DC, 4Peter Shalit, MD, Seattle, WA, 5Southwest CARE Ctr., Santa Fe, NM, 6Gilead Sci., Inc, Foster City, CA.
Financial Disclosures:  R. Elion,
Gilead Sciences, Inc Role(s): Consultant, Research Relationship, Speaker's Bureau.
J. Gathe,
Gilead Sciences, Inc Role(s): Consultant, Research Relationship, Speaker's Bureau.
B. Rashbaum,
Gilead Sciences, Inc Role(s): Research Relationship.
P. Shalit,
Gilead Sciences, Inc Role(s): Consultant, Investigator, Speaker's Bureau.
T. Hawkins,
Gilead Sciences, Inc Role(s): Consultant, Investigator, Speaker's Bureau.
H. C. Liu,
Gilead Sciences, Inc Role(s): Employee, Shareholder (excluding diversitied mutual funds).
L. Zhong,
Gilead Sciences, Inc Role(s): Employee, Shareholder (excluding diversitied mutual funds).
D. R. Warren,
Gilead Sciences, Inc Role(s): Employee, Shareholder (excluding diversitied mutual funds).
B. P. Kearney,
Gilead Sciences, Inc Role(s): Employee, Shareholder (excluding diversitied mutual funds).
S. L. Chuck,
Gilead Sciences, Inc Role(s): Employee, Shareholder (excluding diversitied mutual funds).
Abstract: Background: Suppression of HIV depends on adherence to HAART, which is aided by using a single-tablet once daily regimen. COBI is devoid of anti-HIV activity and boosts the integrase inhibitor EVG and atazanavir (ATV) equivalent to ritonavir (RTV). These two Phase 2 studies compared the efficacy of two single-tablet regimens and two boosting agents.
Methods: Eligible subjects (HIV-1 RNA ≥5,000 copies/mL; CD4 >50 cells/mm3; no resistance or exposure to NRTIs, NNRTIs, or PIs) for 2 prospective, double-blind, active-controlled studies were randomized 2:1 (stratified by HIV RNA ≤ or >100,000 c/mL) to receive: Quad or Efavirenz (EFV)/FTC/TDF, or ATV boosted by either COBI (ATV/co) or RTV (ATV/r) each with FTC/TDF.
Results:
Week 48Quad
n=48		EFV/FTC/TDF
n=23		ATV/co
n=50		ATV/r
n=29
HIV RNA < 50 copies/mL (ITT, M=F)*
HIV RNA < 50 copies/mL (ITT, M=E)
Increase in Mean CD4 cells/mm3
Drug-related AEs (Grades 1-4)
eGFR†: Mean Δ, mL/min (Mean % Δ)		90%
96%
240
46%
-20 (-14%)		83%
95%
162
57%
-6 (-4%)		82%
91%
230
36%
-13 (-12%)		86%
96%
206
48%
-14 (-11%)
Discontinuations
Due to adverse event (AE)		3
0		3
1		5
2		3
1

*HIV RNA stratum-weighted differences at WK 48: (Quad - EFV/FTC/TDF) = 8.4% (95% CI: -8.8% to 25.6%); (COBI - RTV) = -4.6% (95% CI: -21.7% to 12.5%)
†Estimated glomerular filtration rate by Cockcroft-Gault
Conclusions: Quad was well tolerated and maintained a high rate of virologic suppression (90%) that was non-inferior to EFV/FTC/TDF (83%). ATV/co + FTC/TDF was safe with efficacy similar to ATV/r +FTC/TDF through 48 weeks. In treatment arms receiving COBI, early changes in eGFR seen through 24 weeks were stable and similar to that seen in the arm receiving ritonavir.



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